Documentation Specialist (m/f)

REFERENZNUMMER:

273417/11

IHRE AUFGABEN:

-Working in the department "Pharmaceutical & Analytical Development (PHAD) Oral Team Supply", supporting the Global Drug Supply Management group
-Compile and review GMP compliant manufacturing documentation for clinical supplies in an electronic batch recording system in close collaboration with formulation experts and manufacturing operators
-Compile the master batch records based on information provided by the formulation experts and prepare the batch records for review by the formulation experts and for approval by quality assurance
-Contribute to continuous improvement of the manufacturing documentation in a newly introduced electronic batch recording system (PAS-X from Werum) within a team of documentation specialists
-In addition, you perform other administrative tasks, e.g. writing of SOPs, writing of cleaning validation assessments

IHRE QUALIFIKATIONEN:

-Pharmaceutical education (apprenticeship or equivalent)
-Good knowledge of English and German is required
-Good experience in GMP-compliant manufacturing documentation and basic knowledge of manufacturing processes for solid dosage forms
-Knowledge in PAS-X (Werum-system) is of advantage

WEITERE QUALIFIKATIONEN:

Clinical data manager